Gabather AB announces that the Company has signed a Collaborative Agreement with the Centre for Neuropsychiatric Schizophrenia Research at the Psychiatric Centre in Glostrup to conduct a so-called clinical phase II study with GT-002 in patients diagnosed with schizophrenia. The clinical trial has been made possible by a contribution from the Innovation Fund Denmark (IFD) and will test the effect of GT-002 on EEG patterns and cognitive parametres in schizophrenia. The total budget for the study corresponds to approximately 18.6 MSEK amounting to 12 MDKK. The findings of this study hold the promise of unveiling novel avenues for treating patients with schizophrenia. Funded by an Investment Agreement from the Innovation Fund Denmark (IFD), it will now be possible to conduct the first study with GT-002 in patients with schizophrenia. The study is a double-blind randomised so-called phase II study investigating the effect of GT-002 compared to placebo and an active comparator. The 3-year study, aiming at recruiting 20 patients and 30 healthy volunteers will be conducted by the Centre for Neuropsychiatric Schizophrenia Research (CNSR), with Professor Bjørn H. Ebdrup, head of research at the CNSR, as the Principal Investigator. CNSR is a well-recognised psychiatric centre with many years of experience seeing patients with different neuropsychiatric disorders. GT-002 has completed 3 clinical trials in healthy volunteers and has been shown to be safe and well tolerated. The most recent target engagement study showed clinically relevant effects of GT-002 on modulation of EEG frequency band power with a significant increase in alpha band power. This effect spanned various brain regions, including frontal and occipital areas. The results suggest a distinct effects of GT-002 to modulate alpha band
power across specific cortical regions. EEG alpha band power is recognised as a marker of cognitive activity such as attention and is associated with relaxation and reduced anxiety. Modulation of EEG alpha band power
could be beneficial for several neuropsychiatric conditions, especially negative symptoms in schizophrenia that has been shown to be associated with reduced EEG alpha band power.